BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    ERIKA DE REYNOSA, S.A. DE C.V.

    Reg #: 3015335038 · FEI: 3015335038 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    36
    Establishment Types
    1
    Classifications
    10

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    Registration Details

    Registration Name
    ERIKA DE REYNOSA, S.A. DE C.V.
    Registration Number
    3015335038
    FEI Number
    3015335038
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    MIKE ALLEN 1011, PARQUE INDUSTRIAL REYNOSA
    City
    CD, REYNOSA Tamaulipas
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K043363

    Owner / Operator

    Firm Name
    Fresenius Medical Care Renal Therapies Group, LLC
    Operator Number
    9030510
    Address
    920 WINTER STREET, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US
    Correspondent
    Rachel Lloyd

    US Agent

    Business Name
    Fresenius Medical Care North America
    Contact Name
    Denise Oppermann
    Address
    920 Winter St
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    781 9969103

    Products

    Device Name Product Code
    System, Peritoneal, Automatic Delivery FKX
    Set, Administration, For Peritoneal Dialysis, Disposable KDJ
    Protector, Transducer, Dialysis FIB
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Subsystem, Water Purification FIP
    Accessories, Blood Circuit, Hemodialysis KOC
    Disinfectant, Dialysate Delivery System NII
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Autonomous Extracorporeal Blood Leak Detector/Alarm ODX
    Hemodialysis System For Home Use ONW

    Proprietary Names

    Liberty Drain Line Fresenius Sterile Stay Safe Cap Cycler Drain Bag Set CATHETER ADAPTER SEALING CAP stay•safe Catheter Extension Sets Transducer Protectors 5008X CAREsystem PD Cycler Set with 2 Triggers PD Cycler Set with 1 Trigger 2008K@HOME HEMODIALYSIS MACHINE CombiSet - 2008 Series Home Hemodialysis with Prime Bag CritLine IV System CombiSet SMARTECH Hemodialysis Blood Tubing Sets 4 LEAD ECO PREFILLED W/SNAP DISCONNECT 2008T BlueStar Hemodialysis Machine Combiset Blood Line 5008X Hemodialysis System CombiSet Hemodialysis Blood Tubing Set Fresenius Combilines Blood Tubing Set Safe-Lock catheter adapter Co-Pack II Fresenius Bloodlines Patient Connector (HemaClip) stay safe Drain Set Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors APD Luer Lock Adapter Liberty Cycler Set StaySafe Handi-Tool StaySafe Organizer StaySafe Clip StaySafe Organizer Holder Fresenius Combilines Single Needle Blood Tubing Set Fresenius Standalone Access Flow Reserving Connector Combilines Hemodialysis Blood Tubing Set Fresenius BVM Hemodialysis Blood Tubing Set with Priming Set Safe-Lock Universal Connector Fresenius Priming Set with Needless Access Port Crit-Line Clip (CLiC) Blood Chamber

    Establishment Types

    Manufacture Medical Device